510(k) · Cleared
ClearedAtlantis PV Imaging Catheter, Model 36456
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific, Target · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Nov 21, 2002 as substantially equivalent to K890772 (Boston Scientific Corp, 1989) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Nov 21, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K890772 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK890772 Ultrasonic Imaging Catheter for Cardiac Appli.Boston Scientific Corp · 1989
- This deviceK022860 Atlantis PV Imaging Catheter, Model 36456Boston Scientific, Target · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890772 | Ultrasonic Imaging Catheter for Cardiac Appli. | Boston Scientific Corp | 1989 | — |
| 0 (this device) | K022860 | Atlantis PV Imaging Catheter, Model 36456 | Boston Scientific, Target | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K890772 | Ultrasonic Imaging Catheter for Cardiac Appli.Summary page 1…6 I K890772 May 10,1989 (6F / 20 MHz) BSS Sonicath Ultr… | 1989 |
| * | K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra…Summary page 1…K890772 May 10,1989 (6F / 20 MHz) BSS Sonicath UltraTM K970049 June 20,1997 3.2 (3.2F / 20 MHz)… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The AtlantisTMPV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022860: Atlantis PV Imaging Catheter, Model 36456.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022860
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026